NCT05457686

Brief Summary

In this prospective, randomized controlled trial; To evaluate the effect of kinesiology taping applied for edema on pain, edema and functions in the early period after total knee replacement.Patients who underwent total knee replacement will be included in the 10-day follow-up study.Patients will be divided into three groups by randomization. A conservative postoperative physiotherapy program, which is routinely applied to all groups, will be applied. Thus, no patient will be left without treatment. The first group will be considered as the control group, which will be given only a conservative physiotherapy program. In addition to the conservative postoperative physiotherapy program, the 2nd group will be taped without applying tension with a plaster and will be considered as the sham group. In the third group, in addition to the conservative postoperative physiotherapy program, kinesiotaping for payment will be applied.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
187

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 14, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

July 14, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2023

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2023

Completed
Last Updated

February 23, 2023

Status Verified

February 1, 2023

Enrollment Period

7 months

First QC Date

July 3, 2022

Last Update Submit

February 22, 2023

Conditions

Keywords

knee arthroplastykinesiotaping

Outcome Measures

Primary Outcomes (4)

  • edema

    thigh, knee and leg diameter measurements to be measured with a tape measure

    1 day before surgery

  • edema

    thigh, knee and leg diameter measurements to be measured with a tape measure

    1 days after surgery

  • edema

    thigh, knee and leg diameter measurements to be measured with a tape measure

    3 days after surgery

  • edema

    thigh, knee and leg diameter measurements to be measured with a tape measure

    10 days after surgery

Secondary Outcomes (4)

  • Pain Intensity

    1 day before surgery

  • Pain Intensity

    1 day after surgery

  • Pain Intensity

    3 days after surgery

  • Pain Intensity

    10 days after surgery

Other Outcomes (8)

  • Functionality

    1 day before surgery

  • Functionality

    1 day after surgery

  • Functionality

    3 days after surgery

  • +5 more other outcomes

Study Arms (3)

kinesiology group

EXPERIMENTAL

In the group receiving kinesiology treatment, kinesiotaping is applied to the sub-knee region in accordance with the lymphatic correction technique from the first postoperative day to reduce edema and pain. Accordingly, the proximal part of the tape is placed close to the lymph node. In our study, as stated in the literature, the proximal part of the tape will be adhered to the fibular head area next to the lymph nodes without applying any stretching. Then 5-10% stretching is applied and the distal part is adhered. 2 separate bands are applied so that the strips cross each other (from the medial and lateral of the knee). On the first postoperative day, on the third day, the patients will be taped with kinesio tape and discharged on the fourth day. After discharge, they will be asked to remove the tapes after 3 days as they were taught.

Other: kinesio tapeOther: Exercise

sham taping group

SHAM COMPARATOR

Sham application will be taped with a plaster from the same area on the same days as the kinesio application. No tension will be applied while taping. The difference of the plaster from the kinesiotape is that it does not contain tension and does not allow stretching.

Other: Sham tapingOther: Exercise

only physical therapy group(control group)

OTHER

Conservative will be explained on the second day after the operation. Go for a visit with a local cold application 20 times once a day. Ankle pumping exercises, deep breathing exercises, isometric and hip exercises will be planned with a load that can be applied to students who are being applied for bed training. Increased the number and allowance of exercises; isotonic knee and exercises that make you feel It will be added. You will be discharged on the 4th day after the surgery on the 2nd or 3rd day. You will do home exercises after discharge. On the 10th day, you will be called for control.

Other: Exercise

Interventions

According to this, the proximal part of the band is located close to the lymph node. In our study, as stated in the literature, the proximal part of the tape will be adhered to the fibular head area next to the lymph nodes without applying any stretching. Then 5-10% stretching is applied and the distal part is adhered. 2 separate tapes are applied so that the strips cross each other

kinesiology group

In the same procedure and time as kinesiotaping, inelastic tape will be used instead of kinesiotape.

sham taping group

Routine exercise and physiotherapy program applied after knee arthroplasty surgery will be applied

kinesiology grouponly physical therapy group(control group)sham taping group

Eligibility Criteria

Age40 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Performing total knee joint arthroplasty due to stage 4 gonarthrosis
  • Agree to participate in the study
  • Having signed the informed consent form

You may not qualify if:

  • Presence of malignancy, infection, rheumatological disease
  • Having a tape allergy
  • Having a diagnosis of lymphedema

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahievran university

Kirşehi̇r, 40100, Turkey (Türkiye)

Location

Related Publications (3)

  • Boguszewski D, Tomaszewska I, Adamczyk JG, Bialoszewski D. Evaluation of effectiveness of kinesiology taping as an adjunct to rehabilitation following anterior cruciate ligament reconstruction. Preliminary report. Ortop Traumatol Rehabil. 2013 Oct 31;15(5):469-78. doi: 10.5604/15093492.1084361.

    PMID: 24431257BACKGROUND
  • Jongbloed L, van Twist D, Swart N. Kinesio Taping Improves Pain, Range of Motion, and Proprioception in Older Patients With Knee Osteoarthritis. Am J Phys Med Rehabil. 2016 Jan;95(1):e7. doi: 10.1097/PHM.0000000000000393. No abstract available.

    PMID: 26390398BACKGROUND
  • Guney Deniz H, Kinikli G, Onal S, et al THU0727-HPR Comparison of kinesio tape application and manual lymphatic drainage on lower extremity oedema and functions after total knee arthroplasty Annals of the Rheumatic Diseases 2018;77:1791.

    BACKGROUND

MeSH Terms

Conditions

PainEdema

Interventions

Athletic TapeExercise

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BandagesEquipment and SuppliesOrthotic DevicesOrthopedic EquipmentSurgical EquipmentMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
This study was designed as blinded, randomized and controlled.the person who evaluates the patients before and after the treatment is blind.In other words,the person evaluating the patients and the person giving the treatment are different.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant proffesor

Study Record Dates

First Submitted

July 3, 2022

First Posted

July 14, 2022

Study Start

July 14, 2022

Primary Completion

February 12, 2023

Study Completion

February 22, 2023

Last Updated

February 23, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations